← FDA DRUG APPROVALS

FDA ANDA · ANDA201962

VARENICLINE

Sponsor: APOTEX

APPLICATION
ANDA201962
TYPE
ANDA
ORIGINAL APPROVAL
2023-01-25
LATEST ACTION
2023-07-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

VARENICLINE TARTRATEPrescription
VARENICLINE TARTRATE EQ 1MG BASE · TABLET · ORAL
VARENICLINE TARTRATEPrescription
VARENICLINE TARTRATE EQ 0.5MG BASE · TABLET · ORAL

Approval history

2023-07-18Manufacturing (CMC) · Supplement 3 · unknownAP
2023-01-25Not Applicable · OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →